NCT00687349

Brief Summary

This research study is a randomized trial to evaluate a training program that is designed to improve the communication skills of clinicians. The training program focuses on care for patients with serious illnesses and their family members, and assesses effectiveness using patient and family outcomes. The long term goal of this research is to improve communication skills of doctors and nurses, thereby improving patient and family outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,086

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

5.8 years

First QC Date

May 28, 2008

Last Update Submit

September 13, 2014

Conditions

Keywords

End-of-Life issuesTalking with your doctorCoping with chronic illness

Outcome Measures

Primary Outcomes (1)

  • Patient and family ratings on the "End-of-Life domain" of the Quality of Communication Questionaire (QOC)

    4/1/2007-3/31/2012

Secondary Outcomes (2)

  • Patient symptoms of depression as assessed by the PHQ-8 (Memorial Symptom Assessment scale)

    4/01/2007-3/31/2012

  • Patient-, family-, and nurse-assessed ratings of the quality of end-of-life care provided by study clinicians using Quality of End-of-Life Care questionaire

    4/01/2007-3/31/2012

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The training program will assign resident or NP student to a rotation. They will be receiving the educational intervention during 8 half-day sessions.

Behavioral: Training Program Intervention

Control Arm

NO INTERVENTION

Resident or NP student is assigned to usual education.

Interventions

Resident or NP Student receives the educational intervention during 8 half-day sessions.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician:
  • all internal medicine residents at either University of Washington (UW)or the Medical University of South Carolina
  • who have a clinical rotation allowing implementation of the intervention.
  • NP Student:
  • All NP Students at UW or MUSC
  • in programs that train them to work with the following patient types:
  • Adult patents with Cancer or other chronic, life-limiting illnesses
  • Older Adults
  • Adults Primary Care Patients
  • Patient:
  • One or more of the following diagnostic criteria:
  • Advanced Cancer;
  • Chronic obstructive pulmonary disease (COPD) with FEV1 values \< 35% predicted and/or oxygen dependent;
  • Restrictive lung disease with a TLC \< 50% predicted;
  • Congestive heart failure with an ejection fraction \<30% or functional deficits matching New York Heart Association Class III or IV heart failure;
  • +9 more criteria

You may not qualify if:

  • less than 18 years,
  • significant dementia, delirium, or psychosis;
  • the inability to speak English well enough to be able to complete the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Washington; Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Veteran's Affairs Puget Sound HCS

Seattle, Washington, 98108, United States

Location

University of Washington; UW Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • Curtis JR, Back AL, Ford DW, Downey L, Shannon SE, Doorenbos AZ, Kross EK, Reinke LF, Feemster LC, Edlund B, Arnold RW, O'Connor K, Engelberg RA. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081.

  • Ford DW, Downey L, Engelberg R, Back AL, Curtis JR. Association between Physician Trainee Self-Assessments in Discussing Religion and Spirituality and Their Patients' Reports. J Palliat Med. 2014 Apr;17(4):453-62. doi: 10.1089/jpm.2013.0388. Epub 2014 Mar 20.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart FailureEnd Stage Liver Disease

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • J. Randall Curtis, MD, MPH

    University of Washington, Div. of Pulmonary and Critical Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

April 1, 2007

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations